MAUDE Adverse Event Report: ST. JUDE MEDICAL AGILIS NXT STEERABLE INTRODUCER DUAL-REACH 61 CM SHEATH, SMALL CURL DUAL-REACH; INTRODUCER, CATHETER

Model Number G408318

Device Problem Gas/Air Leak (2946)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

The results, method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During an af procedure, an air leak occurred.While inserting the device, air was aspirated into a syringe that connected to the extension part of the sheath.Several aspirations were attempted no air was aspirated.Air was aspirated into the syringe again before re-inserting a ablation catheter into the sheath.No air was aspirated after several aspiration.The procedure was completed with the same sheath with no adverse patient consequences.

Manufacturer Narrative

One 8.5f agilis steerable introducer sheath was received for evaluation.The sheath passed pressure and aspiration leak testing with no anomalies observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• Brand Name: AGILIS NXT STEERABLE INTRODUCER DUAL-REACH 61 CM SHEATH, SMALL CURL DUAL-REACH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 11032371
• MDR Text Key: 222399347
• Report Number: 3008452825-2020-00696
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734206112
• UDI-Public: 05414734206112
• Combination Product (y/n): N
• PMA/PMN Number: K061363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: G408318
• Device Catalogue Number: G408318
• Device Lot Number: 7525931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 02/05/2021
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1